Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients

Phase 2

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Iruplinalib

• Registration Number: NCT06697990
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
• Confirmed diagnosis of brain metastases or suspected brain metastases
• Iruplinalib is proposed for treatment
• Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
• Adequate organ and marrow function

Exclusion Criteria

• Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
• The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
• The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
• Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iruplinalib	Iruplinalib	The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.

Primary Outcome Measures

Name	Time	Method
Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules	28 days	Cerebrospinal fluid levels of natural killer (NK) cells,CD3+ T cells,CD4+ T cells,CD8+ T cells,tumour necrosis factor alpha(TNF-α), interleukin-6(IL-6), interferon-gamma(IFN-γ), high C-reactive protein(hs-CRP),immunoglobulin A(IgA),immunoglobulin E(IgE),immunoglobulin G(IgG),immunoglobulin M(IgM),intercellular adhesion molecule 1(ICAM-1) and vascular cell adhesion molecule 1(VCAM-1).

Secondary Outcome Measures

Name	Time	Method
Iruplinalib concentration in cerebrospinal fluid	Day 28	Iruplinalib concentration in cerebrospinal fluid.
Objective response rate	16 weeks	Objective response rate is defined as the percentage of participants who have a complete response or partial response.
Disease control rate	16 weeks	Disease control rate is defined as the percentage of participants who have a best overall response of complete response, partial response, or stable disease.
Intracranial objective response rate	16 weeks	Intracranial objective response rate is defined as above for objective Response Rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.
Intracranial disease control rate	16 weeks	Intracranial disease control rate is defined as above for disease control rate but it is only based on intracranial disease in the subset of patients with intracranial lesion.